The Effect of Testosterone Supplementation on Rehabilitation Outcomes

Aging Clinical Trial

Official title:

The Effect of Testosterone Supplementation on Rehabilitation Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037999
• Other study ID #: E2419R
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2002
• Last updated: January 20, 2009
• Start date: April 2001
• Est. completion date: March 2004

Study information

• Verified date: May 2002
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The objective of this project is to determine the safety and efficacy of testosterone supplementation as an adjunct to traditional rehabilitation therapy in the care of deconditioned older men. Our long range goal is to determine whether other hormones (e.g., combined testosterone and growth hormone) are helpful as an adjunct to traditional rehabilitation therapy.

This project is important to the VA health care system because 38% of American veterans are aged (age > 65 years), bioavailable testosterone is diminished in older age men, low testosterone is associated with impaired muscle strength, and lack of muscle strength hinders rehabilitation. Older men who are not successfully rehabilitated often get admitted to nursing homes for long term care, at a cost of approximately $40,000/year. Payment for long term care is currently one of our most difficult health care problems. If testosterone supplementation improves rehabilitation outcomes, as our pilot data suggest it will, patients will be more satisfied and long-term care financial resources will be saved.

We will conduct a randomized, placebo-controlled trial to test the hypothesis that supplementation with testosterone improves rehabilitation outcomes in deconditioned older men. Specifically, we will screen all hospitalized older men with delayed discharge from the hospital (> 7 day hospital stay). Men who have at least one new impairment in their ability to perform activities of daily living (e.g., inability to walk), low serum testosterone concentration, and no contraindications (e.g., prostate or breast cancer) will be offered the opportunity to participate. Study participants will be randomized to receive either testosterone (5 mg transdermally each night) or placebo (matching transdermal patch) daily in a double-blind fashion for the duration of their hospital course (expected average duration of study is 29 days). Subjects will then receive their rehabilitation as usual, with all members of the health care team blinded as to whether the subject is receiving testosterone or placebo. At baseline, weekly, at discharge, and at 6 and 12 months after discharge, subjects will be assessed using validated measures (i.e., Functional Independence Measure - FIM). Our hypothesis is that testosterone supplementation, as an adjunct to traditional rehabilitation therapy, will improve rehabilitation outcomes.

Description:

Our overall goal is to determine the safety and efficacy of testosterone supplementation as an adjunct to traditional rehabilitation therapy on health outcomes in deconditioned older men. Specifically, we will conduct a randomized, placebo-controlled trial to test the hypothesis that supplementation with testosterone improves rehabilitation outcomes in deconditioned older men. We will use objective validated measures (i.e., FIM, muscle strength) to assess health outcomes.

We will begin enrolling subjects within three months of receipt of funding, and study 60 subjects (30 in each group) within 24 months. All subjects will undergo follow-up evaluation 6 and 12 months after completion of inpatient rehabilitation and cessation of testosterone supplementation. Therefore, this project will be completed within 3 years. Our short term goal (within 3 years) is to delineate the safety and efficacy of testosterone supplementation on rehabilitation outcomes in deconditioned older men. Our long range goal is to determine whether other hormones (e.g., combined testosterone and growth hormone) are helpful as an adjunct to traditional rehabilitation therapy in the care of older men

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older
• Eligibility: Older men with diminished muscle strength

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Frail Elderly
• Rehabilitation

Intervention

Procedure:
• Testosterone supplement

Locations

Country	Name	City	State
United States	VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,